Fracture fixation system and method

ABSTRACT

A cerclage adjunct device including a plate, having a plurality of lateral extending bores passing through the plate, with the laterally extending bores configured to accommodate a length of binding under tension when the plate is placed in contact with a bone, and with the plurality of laterally extending bores disposed at a fixed longitudinal distance relative to each other.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional ApplicationNo. 62/865,676 filed on Jun. 24, 2019 and U.S. Provisional ApplicationNo. 62/905,017 filed Sep. 24, 2019, which are incorporated herein byreferenced in their entirety.

FIELD OF THE INVENTION

This application relates generally to apparatuses, devices, and methodsfor cerclage and more particularly to apparatuses, devices, and methodsfor cerclage related to femoral fracture fixation.

BACKGROUND

Femoral fractures may occur naturally or iatrogenically during total hiparthroplasty. Depending on the fracture pattern, cerclage alone,cerclage with a plate or plates, cerclage with a strut, cerclage with anextended hip stem, or cerclage with a combination of plates, struts,and/or extended hip stems may be used for bone fixation. However, aproblem with cerclage is that it may create poor bone unions withoutusing additional support devices. In particular with total hiparthroplasty using additional support may not be desirable or possible.With femoral fractures, there may be a high load on the cerclage wiresresulting in adjacent boney erosion and loss of fixation due to wiremigration.

There is a need for a cerclage device that provides improved bone unionswhile minimizing boney erosion and loss of fixation due to wiremigration.

SUMMARY

The present invention provides in one aspect, a cerclage adjunct deviceincluding a plate, having a plurality of lateral extending bores passingthrough the plate, with the laterally extending bores configured toaccommodate a length of binding under tension when the plate is placedin contact with a bone, and with the plurality of laterally extendingbores disposed at a fixed longitudinal distance relative to each other.

Another aspect of the present invention provides a cerclage adjunctdevice including a plate, having points of contact with a bone, aplurality of bores passing laterally through the plate and disposed at afixed longitudinal distance relative to each other. A length of bindingunder tension, passes through each bore of the plurality of bores, andis positioned around a bone.

A further aspect of the present invention provides a method of cerclagefixation including aligning a fractured bone and placing a cerclageadjunct device on the fractured bone, the cerclage adjunct device havinga plate and a plurality of bores disposed laterally through the plate ata fixed longitudinal distance relative to each other. The method furtherincludes, threading a binding through the each bore of the plurality ofbores and placing the binding around the bone, and immobilizing the boneby imparting tension to the binding.

Another aspect of the present invention provides a cerclage adjunctdevice insertion tool including, a handle, an elongated neck extendingfrom the handle, and a wire guide extending from the elongated neck anddistal from the handle. The wire guide is configured for guiding alength of binding into a wire bore of a cerclage adjunct device, and thewire guide configured for attachment to the cerclage adjunct device bythe length of binding.

A further aspect of the present invention provides a method ofconnecting a cerclage adjunct device to a femur including, connectingthe cerclage adjunct device to a cerclage adjunct device insertion tool.The cerclage adjunct device has an elongated body with a plurality oftransverse wire bores passing through the elongated body, a bottomsurface, and a top surface. The cerclage adjunct device insertion toolhas a handle, a neck, a plurality of wire guides, with the plurality ofwire guides aligned with the plurality of wire bores. The method furtherincludes inserting a length of binding through each of the plurality ofwire guides and through the plurality of wire bores, the length ofbinding having a first end and a second end, inserting the first end ofthe length of binding between tissue and a bone, with the bone having analigned fracture, such that the length of binding encircles the bone.Further inserting the cerclage adjunct device between tissue and thebone, pushing the cerclage adjunct device to a position proximal to thealigned fracture, removing the cerclage adjunct device insertion tooland disconnecting from the length of binding, inserting the first endand the second end of the length of binding into a locking mechanism,and placing the length of binding under tension, such that the bottomsurface of the cerclage adjunct device is in contact with the bone.

The present invention in a further aspect provides, a compressivecerclage system having a first plate with a plurality of laterallyextending wire bores passing therethrough, and a plurality of screwbores extending from a top surface through a bottom surface of the firstplate. The compressive cerclage system further having an opposablesecond plate having a top surface, a bottom surface, and a plurality oflaterally extending wire bores passing therethrough. A plurality ofbindings pass through the laterally extending wire bores of the firstplate and the laterally extending wire bores of the second plate toconnect the first plate with the second plate. The plurality oflaterally extending wire bores of the first plate are disposed at afirst fixed longitudinal distance separate from each other relative to alongitudinal dimension of the first plate and the plurality of laterallyextending wire bores of the second plate are disposed at a second fixedlongitudinal distance separate from each other relative to alongitudinal dimension of the second plate.

The present invention in a still further aspect provides, a method ofcerclage fixation including aligning opposing portions of a fracturedbone to set the bone, placing a cerclage adjunct device plate on thefractured bone, the cerclage adjunct device plate having a first platehaving a plurality of wire bores disposed laterally through the firstplate at a fixed longitudinal distance relative to each other, and aplurality of screw bores extending from a top surface through a bottomsurface of the first plate. The method further includes placing acerclage adjunct device on an opposite side of the fractured bone, thecerclage adjunct device having a second plate and a plurality of wirebores disposed laterally through the second plate at a fixedlongitudinal distance relative to each other. A binding is then threadedthrough each wire bore of the plurality of bores of the cerclage adjunctdevice plate and through each wire bore of the plurality of wire boresof the cerclage adjunct device, immobilizing the bone by impartingtension to the binding.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood more fully from the detaileddescription given hereinafter and from the accompanying drawings of thepreferred embodiment of the present invention, which, however, shouldnot be taken to limit the invention, but are for explanation andunderstanding only.

FIG. 1 is a superior perspective view of a two-wire cerclage adjunctdevice, in accordance with an aspect of the present invention;

FIG. 2 is a superior perspective view of a three-wire cerclage adjunctdevice, in accordance with an aspect of the present invention;

FIG. 3 is a longitudinal cross-sectional view of the cerclage adjunctdevice of FIG. 1, in accordance with an aspect of the present invention;

FIG. 4 is a longitudinal cross-sectional view of the cerclage adjunctdevice of FIG. 2, in accordance with an aspect of the present invention;

FIG. 5 is a frontal cross-sectional view of the cerclage adjunct deviceof FIG. 1, in accordance with an aspect of the present invention;

FIG. 6 is a frontal cross-sectional view of the cerclage adjunct deviceof FIG. 2, in accordance with an aspect of the present invention;

FIG. 7 is a side perspective view of the cerclage adjunct device of FIG.1, in accordance with an aspect of the present invention;

FIG. 8 is a side perspective view of the cerclage adjunct device of FIG.2, in accordance with an aspect of the present invention;

FIG. 9 is an inferior perspective view of the cerclage adjunct device ofFIG. 1, in accordance with an aspect of the present invention;

FIG. 10 is an inferior perspective view of the cerclage adjunct deviceof FIG. 2, in accordance with an aspect of the present invention;

FIG. 11 is a lateral cross-sectional view of the cerclage adjunct deviceof FIG. 2, in accordance with an aspect of the present invention;

FIG. 12 is a longitudinal cross-sectional view of the cerclage adjunctdevice of FIG. 1 with a hollow interior, in accordance with an aspect ofthe present invention;

FIG. 13 is a frontal cross-sectional view of the cerclage adjunct deviceof FIG. 1 with a hollow interior, in accordance with an aspect of thepresent invention;

FIG. 14 is a superior perspective view of the cerclage adjunct device ofFIG. 1 connected with a length of binding to a femur, in accordance withan aspect of the present invention;

FIG. 15 is a perspective view of a femur with hip replacement componentsand the cerclage device of FIG. 2, in accordance with an aspect of thepresent invention;

FIG. 16 is a cross sectional view of the femur with hip replacementcomponents and the cerclage device of FIG. 2, in accordance with anaspect of the present invention;

FIG. 17 is a perspective view of a femur with the cerclage device ofFIG. 2, in accordance with an aspect of the present invention;

FIG. 18 is a perspective view of a cerclage adjunct insertion tool, inaccordance with an aspect of the present invention;

FIG. 19 is a perspective view of the cerclage adjunct insertion tool ofFIG. 18 in relation to a femur, in accordance with an aspect of thepresent invention;

FIG. 20 is a perspective view of a length of binding with a lockingmechanism, in accordance with an aspect of the present invention;

FIG. 21 is a perspective view of the locking mechanism of FIG. 20, inaccordance with an aspect of the present invention;

FIG. 22 is a perspective view of a compressive cerclage system affixedto a femur, in accordance with an aspect of the present invention;

FIG. 23 is a longitudinal perspective view of a cerclage adjunct deviceplate of the compressive cerclage system of FIG. 22, in accordance withan aspect of the present invention;

FIG. 24A is a superior perspective view of the cerclage adjunct deviceplate of FIG. 23, in accordance with an aspect of the present invention;

FIG. 24B is a transverse cross section view of the cerclage adjunctdevice plate of FIG. 23, in accordance with an aspect of the presentinvention;

FIG. 24C is a sagittal cross section view of the cerclage adjunct deviceplate of FIG. 23, in accordance with an aspect of the present invention;

FIG. 25 is an inferior perspective view of the cerclage adjunct deviceplate of FIG. 23, in accordance with an aspect of the present invention;

FIG. 26 is a perspective view of the compressive cerclage system of FIG.22, in accordance with an aspect of the present invention;

FIG. 27 is a perspective view of the compressive cerclage system of FIG.22, in accordance with an aspect of the present invention;

FIG. 28 is a lateral perspective view of the compressive cerclage systemof FIG. 22 engaging a femur, in accordance with an aspect of the presentinvention;

FIG. 29 is a medial perspective view of the compressive cerclage systemof FIG. 22 engaging a femur, in accordance with an aspect of the presentinvention; and

FIG. 30 is a perspective view of the compressive cerclage system of FIG.22 affixed to a femur using an oblique truss configuration, inaccordance with an aspect of the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present invention will be discussed hereinafter in detail in termsof various exemplary embodiments according to the present invention withreference to the accompanying drawings. In the following detaileddescription, numerous specific details are set forth in order to providea thorough understanding of the present invention. It will be obvious,however, to those skilled in the art that the present invention may bepracticed without these specific details. In other instances, well-knownstructures are not shown in detail in order to avoid unnecessaryobscuring of the present invention.

Thus, all the implementations described below are exemplaryimplementations provided to enable persons skilled in the art to make oruse the embodiments of the disclosure and are not intended to limit thescope of the disclosure, which is defined by the claims. As used herein,the word “exemplary” or “illustrative” means “serving as an example,instance, or illustration.” Any implementation described herein as“exemplary” or “illustrative” is not necessarily to be construed aspreferred or advantageous over other implementations. Moreover, in thepresent description, the terms “upper”, “lower”, “left”, “rear”,“right”, “front”, “vertical”, “horizontal”, and derivatives thereofshall relate to the invention as oriented in FIG. 1.

The following description references systems, methods, and apparatusesfor use in femoral cerclage fixation. However, those possessing anordinary level of skill in the relevant art will appreciate thatfixation of other bones are suitable for use with the foregoing systems,methods and apparatuses. Likewise, the various figures, steps,procedures and work-flows are presented only as an example and in no waylimit the systems, methods or apparatuses described to performing theirrespective tasks or outcomes in different time-frames or orders. Theteachings of the present invention may be applied to cerclage related toany bone.

Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description. It is also to beunderstood that the specific devices and processes illustrated in theattached drawings, and described in the following specification, aresimply exemplary embodiments of the inventive concepts defined in theappended claims. Hence, specific dimensions and other physicalcharacteristics relating to the embodiments disclosed herein are not tobe considered as limiting, unless the claims expressly state otherwise.

The various embodiments described herein provide for apparatuses,devices, and methods for a cerclage adjunct device for use in fracturefixation. One embodiment is for a cerclage adjunct device for use withcerclage fracture fixation related to femoral and other long bonefractures. A second embodiment is in conjunction with cerclage bonefracture fixation where screws cannot feasibly be used. A thirdembodiment is with cerclage bone fracture fixation where there may beinsufficient space or bone density for the use of screw fasteners. Afourth embodiment is with cerclage bone fracture fixation for use inconjunction with devices using screw fasteners.

FIGS. 1, 3, 5, 7, and 9 refer to a two-wire cerclage adjunct device 100,having a top surface 101, a bottom surface 103, wire bores 102, borewalls 117, bottom holes 104, a plurality of channels 105, and aplurality of ribs 106. A first wire bore 150 and a second wire bore 155of wire bores 102 are depicted bounded by bore walls 117. Two-wirecerclage adjunct device 100 is a longitudinally elongated plate, bowedtoward top surface 101 between lateral edges 116 of the device. Topsurface 101 may, for example, be bowed, such that top surface 101 isconvex and bottom surface 103 is concave between the lateral edges 116of the device. Wire bores 102 pass laterally through the two-wirecerclage adjunct device 100, following a bowed curvature of two-wirecerclage adjunct device 100. Each of wire bores 102 are configured (e.g.shaped and dimensioned) to have a cerclage wire passed through. Two-wirecerclage adjunct device 100 may have, for example, a spacing of 25 mmbetween the midpoint of the wire bores 102 (e.g. the midpoints of firstwire bore 150 and second wire bore 155), as measured in the longitudinaldirection of two-wire cerclage adjunct device 100. The length oftwo-wire cerclage adjunct device 100 in the longitudinal direction maybe, for example, from approximately 30 mm-50 mm. Bottom surface 103 hasalternating channels 105 and raised ribs 106. Channels 105 and ribs 106are shown extending between the lateral edges 116 of the two-wirecerclage adjunct device 100 and disposed along the longitudinal lengthbetween the wire bores 102. On bottom surface 103, bottom holes 104 aredepicted. Bottom holes 104 are depicted extending into and intersectingwire bores 102. The presence of bottom holes 104 may be optional

FIGS. 2, 4, 6, 8, 10, and 11 refer to a three-wire cerclage adjunctdevice 200, having a top surface 201, a bottom surface 203, wire bores202, bore walls 217, bottom holes 204, a plurality of channels 205, anda plurality of ribs 206. There is a first wire bore 250, a second wirebore 255, and a third wire bore 260 of wire bores 202 depicted, boundedby bore walls 217. Three-wire cerclage adjunct device 200 islongitudinally elongated and bowed toward top surface 201 between thelateral edges 216 of the device. Top surface 201 may, for example, bebowed, such that top surface 201 is convex and bottom surface 203 isconcave between the lateral edges 216 of the device. Wire bores 202 passlaterally through the three-wire cerclage adjunct device 200, followinga bowed curvature of three-wire cerclage adjunct device 200. Each ofwire bores 202 (e.g. first wire bore 250, second wire bore 255, andthird wire bore 260) are configured (e.g. shaped and dimensioned) tohave a cerclage wire passed through. Three-wire cerclage adjunct device200 may have, for example, a spacing of 50 mm between first wire bore250 and third wire bore 260 as measured in the longitudinal direction ofthree-wire cerclage adjunct device 200, with second wire bore 255positioned longitudinally in between the first wire bore 250 and thirdwire bore 260. The second wire bore 255 may be spaced, for example,approximately 25 mm from first wire bore 250 and third wire bore 260.However, in some embodiments, second wire bore 255 may be closer to oneof the first wire bore 250 or third wire bore 260. The length ofthree-wire cerclage adjunct device 200 in the longitudinal direction maybe, for example, from approximately 55 mm-70 mm. Bottom surface 203 hasalternating channels 205 and raised ribs 206. Channels 205 and ribs 206are shown extending between the lateral edges 216 of the three-wirecerclage adjunct device 200 and disposed along the longitudinal lengthbetween wire bores 202. On bottom surface 203, bottom holes 204 aredepicted. Bottom holes 204 are depicted extending into and intersectingwire bores 202. The presence of bottom holes 204 may be optional.

Referring to FIG. 11, second wire bore 255 is shown in cross-section anddepicted as bowing between lateral edges 216 of three-wire cerclageadjunct device 200. Also depicted is a bore wall 218 bounding secondwire bore 255. While FIG. 11 refers to three-wire cerclage adjunctdevice 200, second wire bore 255 of wire bores 202 is representative ofwire bores 202 on three-wire cerclage adjunct device 200 and wire bores102 on two-wire cerclage adjunct device 100.

FIGS. 12-13 depict two-wire cerclage adjunct device 100, having, forexample, a hollow interior 107. However, wire bores 102 and wire bores202 may have, for example, solid walls, separating the bore from thehollow interior, such that wire bores 102 and wire bores 202 may supportor brace a cerclage wire, passing through. The above described featuresare applicable to aspects including three-wire cerclage adjunct device200.

Referring to FIGS. 1-11, two-wire cerclage adjunct device 100 andthree-wire cerclage adjunct device 200 may have, for example, a solidinterior, longitudinally elongated plate. In an alternate embodiment,the longitudinally elongated plate may be, for example, of a porousmaterial.

FIG. 14 illustrates a femur 109 having a fracture 110. Femur 109 hasbeen aligned and two-wire cerclage adjunct device 100 has been placed onan outside surface of femur 109, with a binding 108 passing through wirebore 201 and around the circumference of femur 109. Two-wire cerclageadjunct device 100 may be positioned such that, for example, bottomsurface 103 is in contact with the surface of femur 109. Binding 108 isdepicted as passing through first wire bore 150 of two-wire cerclageadjunct device 100 but may also be, for example, passed through secondwire bore 155. Binding 108 may be, for example a wire, a cord, a band,or a cable. The use of the terms wire, cord, band cable and binding maybe used interchangeably.

Referring to FIG. 14, binding 108 may be pulled tight around femur 109using, for example, a tensioner (not shown) and held by a lockingmechanism (not shown) placed onto binding to maintain tension to securethe fracture fixation. When passed through wire bores 102 and placedunder tension, binding 108 may also, for example, secure two-wirecerclage adjunct device 100, pressing bottom surface 103 against thesurface of femur 109.

Three-wire cerclage adjunct device 200 may be positioned similarly totwo-wire cerclage adjunct device 100, with three identical or similarinstances of binding 108 passed through, for example, all three wirebores of three-wire cerclage adjunct device 200. When binding 108 isunder tension, three-wire cerclage adjunct device 200 may be securedagainst femur 109.

While FIG. 14 depicts use with femur 109, two-wire cerclage adjunctdevice 100 (or three-wire cerclage adjunct device 200) may be used forbone fixation to promote bone fusion with a femur having hip replacementimplants, including a femoral stem (not shown).

Referring to FIGS. 1-14, two-wire cerclage adjunct device 100 inhibitsor prevents binding 108 from migrating longitudinally along the bone bymaintaining tension and by remaining secured against the surface offemur 109. The presence of ribs 106 and channels 105 along the bottomsurface 103 provides friction points in contact with femur 109, tofurther prevent migration of binding 108. While two-wire cerclageadjunct device 100 is described, this description also applies tothree-wire cerclage adjunct device 200.

Three-wire cerclage adjunct device 200, with three wire bores (e.g. wirebores 202), would have three lengths of a binding (e.g. binding 108)providing tension on three-wire cerclage adjunct device 200. Bottomsurface 203 is in contact with a bone surface (e.g. of a femur),providing a greater surface area in contact with the bone along thebottom surface with ribs 206 and channels 205, than if wires alone wereused for fixation. Furthermore, bottom surface 203 may distribute (e.g.longitudinally along the bone) the circumferential forces of cerclagewire when in contact with the bone surface. While three-wire cerclageadjunct device 200 is described, this description also applies totwo-wire cerclage adjunct device 100.

Two-wire cerclage adjunct device 100 and three-wire cerclage adjunctdevice 200 may be made from, for example, plastic, or titanium and/orcobalt and/or chrome.

Referring generally to FIGS. 1-11, wire bores 202 of three-wire cerclageadjunct device 200 and wire bores 102 of two-wire cerclage adjunctdevice 100, for example, extend from and between the lateral edges ofeach respective device. Wire bores 202 and 102 may be used to, forexample, channel binding 108. Bore walls 217 bound wire bores 202 andbore walls 117 bound wire bores 102. Bore walls 217 and bore walls 117may, for example, support binding 108 and inhibit or prevent movementlongitudinal to the device (e.g. device 100 or device 200). Bore walls(e.g. bore walls 217 and 117) may be smooth to help binding 108 passthrough. However, other embodiments may include a raised section of topsurface 101 and top surface 201, extending laterally but with the raisedsection between the edges of the respective device, with a bore passingthrough. In another embodiment, instead of a wire bore 102 or wire bore202, for example, a channel or a groove or a recess, extending laterallywithin or on top surface 101 and top surface 102 may be used to supporta wire in contact with three-wire cerclage adjunct device 200 ortwo-wire cerclage adjunct device 100. In another embodiment, forexample, raised hooks or a recess of hooks may be positioned laterallyalong or laterally within top surface 101 and top surface 102.

Binding 108 has, for example, a range of diameters from approximately0.5 mm-3 mm. To accommodate the length of binding, wire bore 102 andwire bore 202 may be wider to accommodate binding 108 passing through.The cerclage adjunct device may be sized for use with specific diametersof binding 108, such that a surgeon may be able to select cerclageadjunct device based on the diameter of the binding 108 used to affix afracture of the bone (e.g. femur 109) sought to be set.

Referring to FIGS. 9-10, three-wire cerclage adjunct device 200 mayhave, for example, ribs 205 and channels 205 on bottom surface 203 andtwo-wire cerclage adjunct device 100 may have ribs 106 and channels 105on bottom surface 103. Alternate embodiments may have, for example, aridged, a rippled, a wavy surface, or any geometry which provides bonesurface contact with a standoff geometry. A still further embodiment maybe, for example, a smooth bottom surface. Embodiments having bottomsurface 103 or bottom surface 203 with a standoff geometry, such as, forexample, ribbed with channels, ridged, rippled, or wavy surfaces mayencourage fluid flow for bone regeneration.

Referring generally to FIGS. 1-11, a lateral width and lateral curvatureof three-wire cerclage adjunct device 200 and two-wire cerclage adjunctdevice 100 may depend on the specific surgical requirements, such as,for example, bone dimensions and bone density. However, the lateralwidth may be, for example, from approximately 10 mm-40 mm. With devicesof, for example, approximately 15 mm wide or less, curvature may beunnecessary, without bowing toward a top surface, between the lateraledges of the device. Devices with lateral widths from approximately 15mm-40 mm may bow toward the top surface between the lateral edges of thedevice. The fit may be further improved if the curvature of the device(e.g. device 100 or device 200) matches that of the bone, for example,having a radius from approximately 10 mm-50 mm, from the approximatecenter of the bone.

While two-wire cerclage adjunct device 100 and three-wire cerclageadjunct device 200 may be described, there may be embodiments havingmore than three wire bores.

FIG. 15 depicts femur 109, having a replacement femoral head 401connected to a superior end of femur 109, and a fracture 110 in femur109. The bones on opposite sides of fracture 110 have been aligned, andthree-wire cerclage adjunct device 200 and a plate 400 have beenfastened to femur 109 using binding 108.

FIG. 16 depicts femur 109 in transverse cross section, with a hipreplacement stem 405 longitudinally positioned (e.g. coaxially aligned)through femur 109. Three-wire cerclage adjunct device 200 is shown inrelation to femur 109, binding 108 of a plurality of lengths of bindingsand plate 400.

FIG. 17 illustrates femur 109 with fracture 110 thereof being alignedand fixed by using a three-wire cerclage adjunct device 200. Three-wirecerclage adjunct device 200 may be connected to plate 400 by a pluralityof lengths of binding 108.

FIGS. 20-21 depict binding 108, with a locking mechanism 111. Binding108 may be, for example a wire, a cord, or a cable. Locking mechanism111 may represent any commercially available locking mechanism forholding binding 108. The use of the terms wire, cord, cable and lengthof binding may be used interchangeably. Binding 108 may have, forexample, a first end and a second end such that binding 108 may beplaced around a bone (e.g. femur 109) with first and second end threadedthrough locking mechanism 111. Binding 108 may be tightened through thelocking mechanism 111 using a tensioning device (not shown). To completefastening, binding 108 may be held in place by the fastener or crimpedbefore excess material is removed.

FIGS. 15-16 depict aspects of the invention for use in bone fixation topromote bone fusion with femur 109 having hip replacement implants,including femoral stem 405. FIG. 17 depicts the aspects of the inventionof FIGS. 15-16 the invention used with femur 109.

Generally referring to FIGS. 15-17, three-wire cerclage adjunct device200 may be positioned in contact with an outside surface of femur 109,such that wire bore 202 is laterally disposed for binding 108 to passthrough wire bore 202 and around a circumference of femur 109. Plate 400may be affixed to femur 109 to aid in bone fixation and fusion. If bonedensity is sufficient to support screws and if there are no impedingobjects, such as hip replacement stem 405, plate 400 may be affixed tofemur 109 using, for example, screws. If screws cannot be used to affixplate 400, a plate may be held in place by binding tension of cerclage,in conduction with the cerclage adjunct device (e.g. 100 or 200), or analternative to a plate may be used. In another embodiment, for example,a strut or a graft may be connected to femur 109 in place of or inaddition to plate 400. A strut or a graft may be placed against a bone(e.g. femur 109) and held in place by binding tension of cerclage, inconduction with the cerclage adjunct device (e.g. 100 or 200). Byplacing binding 108 under tension, contact between three-wire cerclageadjunct device 200 and femur 109 may be promoted. Binding 108 may beplaced under tension by, for example, using a locking mechanism throughwhich ends of binding 108 pass and are prevented from moving freely as atensioner (not shown) may be used to tighten the binding.

Generally referring to FIGS. 1-17, since bindings (i.e., multipleinstances of binding 108) are under tension and threaded through wirebores 202, bore walls 217 prevent bindings (i.e. multiple instances ofbinding 108) from moving longitudinally, thus binding 108 is inhibitedor prevented from slipping. Furthermore, the channels 205 and ribs 206on bottom surface 203 may provide frictional contact with femur 109 inaddition to bone growth encouragement, thereby inhibiting or preventingthree-wire cerclage adjunct device 200 from slipping. While three-wirecerclage adjunct device 200 is described, the described correction tofemur 109 also applies to two-wire cerclage adjunct device 100.

Generally referring to FIGS. 1-17, three-wire cerclage adjunct device200 and two-wire cerclage adjunct device 100 are placed on a bone (e.g.femur 109) and multiple bindings (e.g. multiple instances of binding108) are inserted through wire bores (e.g. wire bores 102 and wire bores202) and around the bone (e.g. femur 109) to secure fracture fixation.Due to the positioning of wire bores (e.g. wire bores 102 and wire bores202), multiple bindings (e.g. multiple instances of binding 108) arecommonly parallel to each other, to maintain binding 108 tension and tominimize or prevent binding 108 from cutting into bone.

FIGS. 18-19 refers to a cerclage adjunct insertion tool 300, having ahandle 301, a neck 302, a wire bore 303, a wire guide 304, and a toolhead 305. Wire bore 303 passes through wire guide 304, with wire guide304 being configured (e.g. shaped and dimensioned) for binding 108 topass through. Cerclage adjunct insertion tool 300 is depicted asconfigured (e.g. shaped and dimensioned) for use with two-wire cerclageadjunct device 100. Two-wire cerclage adjunct device 100 may be placedon femur 109 using tool 300.

Referring generally to FIGS. 18-21, cerclage adjunct insertion tool 300has two wire guides (e.g. two of wire guide 304) and is shown configured(e.g. shaped and dimensioned) for use with two-wire cerclage adjunctdevice 100, having two wire guides (e.g. two of wire guide 102).However, a tool with, for example, three wire guides (e.g. three of wireguide 304), may be configured (e.g. shaped and dimensioned) for use withthree-wire cerclage adjunct device 200, and with the following methodinterchangeably used for either device.

Referring to FIGS. 15-21, fracture 110 of femur 109 may, for example, bealigned and plate 400 may be affixed to femur 109. In a situation wherehip replacement stem 405 is inserted longitudinally through the femur109, the bone (e.g. femur 109) may be too brittle or there may not besufficient space to use screws to secure plate 400 or a strut to thebone. Cerclage adjunct insertion tool 300 may maintain contact withtwo-wire cerclage adjunct device 100 by aligning wire bores 102 withwire guide 304, such that binding 108 is passed through wire guide 304via wire bore 303 and through wire bore 102. Tool 300 and two-wirecerclage adjunct device 100 may be threaded by binding 108 prior tocommencing the surgical procedure or during the surgical procedure.Binding 108 may have a first end and a second end such that first endmay be inserted between bone and tissue, such that first end may bepositioned around femur 109. Two-wire cerclage adjunct device 100 may beinserted between tissue and a bone (e.g. femur 109), following binding108 and using tool 300 to push two-wire cerclage adjunct device 100 intoa position proximal to the aligned fracture. In particular, tool head305 may be in contact with two-wire cerclage adjunct device 100 with asurgeon grasping handle 301, and using cerclage adjunct insertion tool300 to push two-wire cerclage adjunct device 100 into position betweenbone and tissue. Tool 300 alignment with two-wire cerclage adjunctdevice 100 is maintained by threading with binding 108. Advancing forceto two-wire cerclage adjunct device 100 is transmitted via contact withtool head 305. Once positioned, cerclage adjunct device insertion tool300 may be removed and disconnected from binding 108. The first end andthe second end of binding 108 may be inserted into locking mechanism111. Binding 108 may be pulled through locking mechanism 111 placingbinding 108 under tension, such that bottom surface 103 of two-wirecerclage adjunct device 100 is in contact with the bone surface of femur109. Any plate or strut or graft, that may be utilized to hold bonesaligned to set fracture or promote bone growth, would also be encircledby binding 108 (e.g. multiple instances thereof) and held under tensionagainst the bone surface. Three-wire cerclage adjunct device 200 ortwo-wire cerclage adjunct device 200, may be used with plate 400 and/ora strut or a graft, the cerclage adjunct device (e.g. device 100 ordevice 200). Cerclage adjunct device (e.g. device 100 or device 200) maybe positioned on a surface of the bone (e.g. femur 109), with binding108 through the device bores (e.g. wire bores 102 or wire bores 202) andencircling the bone (e.g. femur 109) and plate 400 and/or strut or graftaffixed to the bone (e.g. femur 109).

Cerclage adjunct device (e.g. device 100 or device 200) may also bepositioned on plate 400 or strut or graft, such that bottom surface(e.g. bottom surface 103 or bottom surface 203) is in contact with plate400 or strut or graft. Bindings (e.g. multiple instances of binding 108)may pass through device bores (e.g. wire bores 102 or wire bores 202),encircling a bone (e.g. femur 109), and fastening cerclage adjunctdevice (e.g. device 100 or device 200) as binding 108 is placed undertension and locked into position using locking mechanism 111.

FIG. 22 depicts a compressive cerclage system 600 affixed to femur 109,with the parts of femur 109 on opposite sides of fracture 110 havingbeen aligned. Compressive cerclage system 600 has a cerclage adjunctdevice plate 500, longitudinally aligned on a lateral surface 530 offemur 109. Compressive cerclage system 600 has two-wire cerclage adjunctdevice 100, longitudinally aligned on a medial surface 525 of femur 109.Cerclage adjunct device 100 and cerclage adjunct device plate 500 aredepicted on opposite sides of femur 109 and connected with bindings(e.g. multiple instances of binding 108). Cerclage adjunct device plate500, may have bindings (e.g. multiple instances of binding 108) thatencircle and contact femur 109 without being connected to two-wirecerclage adjunct device 100.

FIG. 23 depicts cerclage adjunct device plate 500 having a top surface501 and a bottom surface 503. Bottom surface 503 is depicted as curvedor bowed toward the top surface 501 between lateral edges 516. Topsurface 501 may, for example, be bowed, such that top surface 501 isconvex and bottom surface 503 is concave between the lateral edges 516of the device.

FIGS. 24A-24C depicts cerclage adjunct device plate 500 having athickness T, a plurality of wire bores 502, and a plurality of screwbores 522. Wire bores 502 are depicted as having a first wire bore 550,a second wire bore 555, a third wire bore 560, a fourth wire bore 565, afifth wire bore 570, a sixth wire bore 575, and a seventh wire bore 580.Wire bores 502 extend laterally through cerclage adjunct device plate500 and are bounded by bore walls 517. Screw bores 522 are depicted ashaving a first screw bore 561, a second screw bore 562, a third screwbore 563, and a fourth screw bore 564. Screw bores 522 extend from topsurface 501 through bottom surface 503, and have a first surface 519 anda screw bore wall 518. Wire bores 502 pass laterally through cerclageadjunct device plate 500, following a bowed curvature of cerclageadjunct device plate 500. Each of wire bores 502 are configured (e.g.shaped and dimensioned) to have binding 108 passed through.

FIG. 25 depicts cerclage adjunct device plate 500 having bottom surface503, the plurality of screw bores 522, with a plurality of alternatingchannels 505 and raised ribs 506. Channels 505 and ribs 506 are shownextending between lateral edges 516 of cerclage adjunct device plate 500and may be disposed along the longitudinal length between wire bores502. Screw bore 564 is depicted extending through cerclage adjunctdevice plate 500 and through the plurality of alternating channels 505and raised ribs 506.

Referring to FIGS. 23-25, cerclage adjunct device plate 500 is depictedwith a lateral width, and a lateral curvature or bowing between lateraledges 516 which may depend on the specific surgical requirements, suchas, for example, bone dimensions and bone density. The lateral width maybe, for example, from approximately 10 mm-40 mm. With devices of, forexample, approximately 15 mm wide or less, curvature may be unnecessary,without bowing toward a top surface, between the lateral edges 516 ofthe device. Devices with lateral widths from, for example, approximately15 mm-40 mm may curve or bow toward the top surface between the lateraledges 516 of the device. The fit may be further improved if thecurvature of the device (e.g. device 100 or device 200) matches that ofthe bone, for example, having a radius from approximately 10 mm-50 mm,from the approximate center of the bone. Cerclage adjunct device plate500 may have, for example, lengths from approximately 25 mm-250 mm inthe longitudinal direction.

Wire bores 502 may be used to, for example, channel binding 108. Wirebores 502 have bore walls 517, bounding wire bores 502 to supportbinding 108 and to inhibit or prevent movement longitudinal to cerclageadjunct device plate 500. Bore walls 517 may be smooth to help binding108 pass through. However, other embodiments may include raised sectionsof top surface 501, extending laterally but with the raised sectionsbetween the edges of the respective device, with wires bores 502 passingthrough. In another embodiment, instead of wire bore 502, for example, achannel or a groove or a recess, extending laterally within or on topsurface 501 may be used to support a wire in contact with cerclageadjunct device plate 500. In another embodiment, for example, raisedhooks or a recess of hooks may be positioned laterally along orlaterally within top surface 501 and top surface 502.

The longitudinal spacing between wire bores 502 may be, for example,approximately 5 mm-100 mm between wire bore 502 midpoints, withpreferred spacing of 20 mm-25 mm between wire bore 502 midpoints. Thelongitudinal spacing between screw bores 522 may be, for example,approximately 10 mm-100 mm between screw bore 522 midpoints, withpreferred spacing of 20 mm-25 mm between screw bore 522 midpoints. Whilewire bores 502 are depicted as evenly spaced longitudinally along aportion of cerclage adjunct device plate 500, the spacing need not beeven and may vary to accommodate bone dimension and/or bone density.Screw bores 522 are depicted as evenly spaced longitudinally along aportion of cerclage adjunct device plate 500, however, the spacing neednot be even and may vary to accommodate bone dimension and/or bonedensity.

Referring to FIGS. 26-27, cerclage adjunct device plate 500 is depictedhaving cerclage adjunct device plate 500 having thickness T, a pluralityof wire bores 502, and a plurality of screw bores 522. Wire bores 502are depicted as having a first wire bore 550, a second wire bore 555, athird wire bore 560, a fourth wire bore 565, a fifth wire bore 570, asixth wire bore 575, and a seventh wire bore 580. Screw bores 522 aredepicted as having a first screw bore 561, a second screw bore 562, athird screw bore 563, and a fourth screw bore 564. Two-wire cerclageadjunct device 100, is depicted with wire bores 102 having a first wirebore 150 and a second wire bore 155. Two-wire cerclage adjunct device100 is depicted as being connected to cerclage adjunct device plate 500with bindings (e.g. multiple instances of binding 108). A first binding508 is depicted connecting first wire bore 150 with second wire bore 555and a second binding 509 is depicted connecting second wire bore 155with third wire bore 560, with first binding 508, second binding 509,and additional bindings (e.g. multiple instances of binding 108)connecting the two devices and encircling the bone (e.g. femur 109).First binding 508 and second binding 509 are most commonly parallel.Screws 543 are depicted as having been inserted through screw bores 522.Screws 543 may be of a locking or non-locking type.

Referring to FIGS. 24A-24C, 26, and 27, cerclage adjunct device plate500 is depicted as having thickness T being thicker in a region 587adjacent to and surrounding screw bores 522. A region 586 with just wirebores 502 is depicted as having thickness T being thinner than theregion 587 surrounding screw bores 522.

Screw bores 522 may be for screw insertion to attach cerclage adjunctdevice plate 500 to femur 109. Screw bores 522 have first surface 519which may be, for example, a counter sunk or a counter bored surface toaccommodate angled or flat headed screws. The first surface providesscrew bores 522 that may accommodate screws 543 fully inserted into boreso that screws 543 may be inserted in the screw bore 522 with minimal orno protrusion above the top surface 501. Screw bore walls 518 may besmooth or grooved to engage with screws 542.

FIG. 28 depicts cerclage adjunct device plate 500, longitudinallyaligned on lateral surface 530 of femur 109. Bindings (e.g. binding 508,binding 509, and multiple instances of binding 108) pass throughcerclage adjunct device plate 500. Also depicted are screws 543 insertedinto second screw bore 562, third screw bore 563, and fourth screw bore564.

FIG. 29 depicts two-wire cerclage adjunct device 100, longitudinallyaligned on medial surface 525 of femur 109. First binding 508 isdepicted as passing through first wire bore 150 and second binding 509is depicted as passing through second wire bore 155. Further depictedare screws 543 passing through femur 109.

Referring to FIGS. 22, and 28-29, cerclage adjunct device plate 500 isdepicted as being loose fitting, with screw 543 only partially tightenedwithin femur 109, and bindings (e.g. multiple instances of binding 108)are also depicted as being loose. Screw 543 may normally be tightenedand bindings 108 may be normally tightened such that lower surface 503of cerclage adjunct device plate 500 is positioned substantially againstthe surface of the bone (e.g. femur 109). Bindings 108 may be placedunder sufficient tension to maintain bone fixation and to promote bone(e.g. femur 109) fusion and healing. A plurality of screws (e.g.multiple instances of screw 543) are depicted as inserted into screwbores 522 (e.g. second screw bore 562, third screw bore 563, and fourthscrew bore 564), through lateral surface 530 (e.g. a first corticalcrossing), and passing out from medial surface 525 (e.g. a secondcortical crossing). The plurality of screws (e.g. multiple instances ofscrew 543) may be used to fasten cerclage adjunct device plate 500 tofemur 109, with multiple bindings (e.g. multiple instances of binding108) being used for bone fixation.

FIG. 30 depicts compressive cerclage system 600 affixed to femur 109,with the parts of femur 109 on opposite sides of fracture 110 havingbeen aligned. Compressive cerclage system 600 has cerclage adjunctdevice plate 500, longitudinally aligned on lateral surface 530 of femur109. Compressive cerclage system 600 has two-wire cerclage adjunctdevice 100, longitudinally aligned on medial surface 525 of femur 109.First binding 508 connects first wire bore 150 with second wire bore 555and second binding 509 connects second wire bore 155 with third wirebore 560. An oblique binding 583 passes through first wire bore 150,connecting with and passing through first wire bore 550 in a trussconfiguration.

Referring to FIGS. 22-30, compressive cerclage system 600 is depictedhaving opposing components on medial surface 525 and lateral surface 530of femur 109, in the form of cerclage adjunct device plate 500 onlateral surface 530 and two-wire cerclage adjunct device 100 on themedial surface 525. Screws 543 may be used to connect cerclage adjunctdevice plate 500 into position, with bindings (e.g. multiple instancesof binding 108) being placed under tension and used to hold the bonefragments in place after fixation has occurred. Placing bindings (e.g.multiple instances of binding 108) under tension creates compressionfrom lateral surface 530 and medial surface 525 of femur 109, and thuspromoting bone fusion. The curvature of cerclage adjunct device plate500 between lateral edges 516 may help promote bone contact byapproximating bone curvature. Bottom surface 503 depicts alternatingchannels 505 and raised ribs 506. Channels 505 and ribs 506 are shownextending between the lateral edges 516 of cerclage adjunct device plate500 and may, for example, be disposed along the longitudinal lengthbetween wire bores 502. Ribs 506 help promote contact between cerclageadjunct device plate 500 and the bone surface of femur 109. Channels 505help promote blood supply between cerclage adjunct device plate 500 andthe bone surface of femur 109.

A longitudinal channel or ridge (not shown) may extend along the lengthof the bottom surface 503. The channel or ridge (not shown) may, forexample, help promote blood supply to the bone surface.

Further referring to FIGS. 22-30, the presence of medial surface 525components (e.g. two-wire cerclage adjunct device 100) and lateralsurface 530 components (e.g. cerclage adjunct device plate 500) ofcompressive cerclage system 600 may provide stability and through theuse of cerclage or cerclage with truss configurations (e.g. usingoblique binding 583), provides support and captures bone fragments topromote bone fusion and healing. While aspects are depicted usingtwo-wire cerclage adjunct device 100 as the component on medial surface525, other aspects may use a three-wire cerclage adjunct device 200, andstill other aspects might use cerclage adjunct devices with more wirebores (e.g. 102 or 202) and bindings (e.g. 108). Aspects of cerclageadjunct device plate 500 are depicted with four screw bores (e.g. firstscrew bore 561, second screw bore 562, third screw bore 563, and fourthscrew bore 564), however, there may be aspects with fewer or more screwbores 522. There may be other aspects with as few as one screw bore andthere may be aspects with more than more than four screw bores. Aspectsof cerclage adjunct device plate 500 are depicted with seven wire bores(e.g. first wire bore 550, second wire bore 555, third wire bore 560,fourth wire bore 565, fifth wire bore 570, sixth wire bore 575, andseventh wire bore 580) however, there may be aspects with fewer or morewire bores 502.

Compressive cerclage system 600 may be used for fracture fixation andbone fusion with, for example, bone breaks involving a hip replacementstem and classified as Vancouver grade B. As such, two-wire cerclageadjunct device 100 would most commonly be positioned on medial surface525 where two-wire cerclage adjunct device 100 would be pushed betweentissue and bone, and with cerclage adjunct device plate 500 positionedon lateral surface 530. Cerclage adjunct device plate 500 may be inclose proximity to an incision and for easier positioning for screw 543insertion. Furthermore, cerclage adjunct device plate 500 would bepositioned so that screw bores 522 may be, for example, below fracture110 for stable attachment to femur 109 with bindings (e.g. multipleinstances of binding 108) used for fracture fixation. In other aspects,cerclage adjunct device plate 500 would be positioned so that screwbores 522 are below fracture 110 and below any implant stem (e.g. hipreplacement stem 405) so that screws (e.g. multiple instances of screw543) would not interfere with fracture 110 or implant stem.

Still referring to FIGS. 22-30, the configuration of aspects may bedirected as the anatomy dictates. Screws 543 are depicted as beinginserted into first screw bore 561, second screw bore 562, and thirdscrew bore 563 but not fourth screw bore 564. There may be, for example,aspects where screws 543 are inserted in fewer than three or all screwbores 522. Binding 108 may be directed into positions where, forexample, diagonal or oblique force is preferred to radial force tostiffen constructs of compressive cerclage system 600. There may beaspects where, for example, oblique bindings (e.g. multiple instances ofoblique binding 583) or a combination of multiple binding 108 andoblique bindings (e.g. multiple instances of oblique binding 583) arepreferred based on anatomy features. There may also be aspects wherebindings (e.g. multiple instances of binding 108) are parallel,maintaining radial tension.

Aspects of the invention described herein include bone fixation offractures to promote bone fusion in femur 109. Those same aspects alsoinclude bone fixation of fracture to promote bone fusion in a femurhaving a hip replacements stem inserted. Aspects of the inventionreferring to cerclage with femur 109 may also be used for cerclage witha femur having a hip replacement stem. Aspects of the inventionreferring to femur 109 with hip replacement stem 405, may also be usedwith femur 109.

While this invention has been described with respect to at least oneembodiment, the present invention can be further modified within thespirit and scope of this disclosure. This application is thereforeintended to cover any variations, uses, or adaptations of the inventionusing its general principles. Further, this application is intended tocover such departures from the present disclosure as come within knownor customary practice in the art to which this invention pertains andwhich fall within the limits of the appended claims.

What is claimed is:
 1. A fracture fixation system comprising: a platehaving a plurality of laterally extending bores passing therethrough,the laterally extending bores configured to receive a length of bindingunder tension when the plate is placed in contact with a bone; and theplurality of laterally extending bores disposed at a fixed longitudinaldistance separate from each other relative to a longitudinal dimensionof said plate.
 2. The system of claim 1, wherein the plate has a topsurface, a bottom surface, the bottom surface configured for contactwith the bone.
 3. The system of claim 2, wherein the bottom surface hasa plurality of lateral channels.
 4. The system as in any of claim 1,wherein the plate further has a lateral curvature, wherein the bottomsurface is concave.
 5. The system of claim 4, wherein the lateralcurvature defines a radius from 10 mm-50 mm from the center of the bone.6. A fracture fixation system comprising: a first plate having aplurality of laterally extending wire bores passing therethrough, and aplurality of screw bores extending from a top surface through a bottomsurface of the first plate; an opposable second plate having a topsurface, a bottom surface, and a plurality of laterally extending wirebores passing therethrough; a plurality of bindings passing through thelaterally extending wire bores of the first plate and the laterallyextending wire bores of the second plate to connect the first plate withthe second plate; the plurality of laterally extending wire bores of thefirst plate disposed at a first fixed longitudinal distance separatedfrom each other relative to a longitudinal dimension of said firstplate; and the plurality of laterally extending wire bores of the secondplate disposed at a second fixed longitudinal distance separated fromeach other relative to a longitudinal dimension of said second plate. 7.The system of claim 6, wherein the first plate and the second plate areconfigured for contact with surfaces of opposite sides of a bone.
 8. Thesystem of claim 7, wherein the bottom surface has a plurality of lateralchannels.
 9. The system of claim 8, wherein the first plate further hasa lateral concave bottom surface curvature; and the second plate furtherhas a lateral concave bottom surface curvature.
 10. The system of claim9, wherein the plurality of laterally extending bores of the secondplate comprises two laterally extending bores.
 11. The system of claim10, wherein the plurality of laterally extending bores of the secondplate comprises three laterally extending bores.
 12. The system of claim6, wherein the first plate and the opposable second plate are configuredfor compression force distribution along points of contact with a bone.13. The system of claim 12, wherein the bone is a femur with the firstplate is positioned on the lateral surface of the femur and the secondplate is positioned on the medial surface of the femur.
 14. The systemof claim 6, wherein the first fixed longitudinal distance is equal tothe second longitudinal distance.
 15. A method of cerclage fixationcomprising: aligning opposing portions of a fractured bone to set thebone; placing a cerclage adjunct device plate on the fractured bone, thecerclage adjunct device plate comprising a first plate having aplurality of wire bores disposed laterally through the first plate at afixed longitudinal distance relative to each other, and a plurality ofscrew bores extending from a top surface through a bottom surface of thefirst plate; placing a cerclage adjunct device on an opposing side ofthe fractured bone, the cerclage adjunct device comprising a secondplate and a plurality of wire bores disposed laterally through thesecond plate at a fixed longitudinal distance relative to each other;threading a binding through each wire bore of the plurality of wirebores of the cerclage adjunct device plate; threading a binding througheach wire bore of the plurality of wire bores of the cerclage adjunctdevice; and immobilizing the bone by imparting tension to the binding.16. The method of cerclage fixation of claim 15, wherein placing thecerclage adjunct device plate on the bone comprises displacing tissue;placing the cerclage adjunct device in position to insert screws;inserting screws through the screw bores; and replacing tissue.
 17. Themethod of claim 15, wherein placing the cerclage adjunct device on thebone comprises placing the cerclage adjunct device under tissue.
 18. Themethod of claim 15, wherein the cerclage adjunct device plate and thecerclage adjunct device distribute compressive forces imparted throughthe tension to the binding.
 19. The method of claim 18, wherein thecerclage adjunct device plate distributes the compressive force alongthe first plate surface on the bone and the cerclage adjunct devicedistributes the compressive force along the second plate surface on thebone.